Supplements lack science, safety proof

"Lost your essence after excessive lovemaking?" BioRay said it has a supplement for you.

Autism? Allergies? Liver problems? BioRay said it can help.

In fact, the supplement company established by Timothy and Stephanie Ray said it has products for just about anything that ails you or your family — from speech delays to weight issues.

It might sound like the world's best apothecary, but neither Timothy nor Stephanie Ray is a licensed medical doctor or pharmacist. There's no strong scientific evidence that their products work or that they are safe. In BioRay's online forum, customers have linked its products to fever, rashes, boils, heart palpitations and more.

Medical experts who were asked to look at some of BioRay's product claims expressed concerns. Dr. Daniel Ganger, a liver specialist, said he worried that people would opt for products like Liver Life, which BioRay's website said can "normalize liver enzymes," instead of getting medical attention.

"It's a joke," said Ganger, associate professor of medicine at Northwestern University's Feinberg School of Medicine.

BioRay, which is located in Laguna Hills, Calif., defended its products, its claims about them and their safety.

"At BioRay we have married ancient Chinese Medicine with science to bring you the most effective all natural products," the company website states.

The company, after questioning by the Tribune, changed wording about its products and staff on its website. The company also shut its public forums and Wiki.

The website also has a disclaimer noting, in part, that its products and content have not been evaluated by the U.S. Food and Drug Administration and that "no action or inaction should be taken based solely on the contents of this information; readers should consult appropriate health professionals on any matter relating to their health and well being."

BioRay is a cautionary tale for consumers whose hope and money fuel the $25 billion supplement industry. Federal law on supplements doesn't require companies to prove products work or are safe. And the law is only intermittently enforced by an overwhelmed FDA.

Last year, the FDA sent warning letters to eight companies for illegally selling supplements as chelators — drugs that help remove metals from the body. But the agency did not send one to BioRay, which, until recently, advertised two of its products as "full spectrum organic chelators" on its website.

The company stopped referring to NDF and NDF Plus, both sold on the BioRay website for $269.95 for 4 ounces, as "chelators" after being contacted by the Tribune. According to BioRay, NDF is its most popular product.

"They don't have enough people (at the FDA)," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "It's grossly inadequate."

Now the FDA has even more to do — ensuring that the more than 16,000 companies that manufacture, package, label or hold supplements sold to U.S. customers comply with a lengthy list of what are known as "Current Good Manufacturing Practices" guidelines. The guidelines, rules governing the manufacturing and testing of supplements for quality, have been phased in over several years, with the last group — very small supplement companies like BioRay — required to comply starting in June 2010.

"They have their hands full," said Duffy MacKay, vice president of scientific and regulatory affairs for the supplement industry trade association Council for Responsible Nutrition. "We really support the full enforcement of current laws and regulations. …We lose consumer confidence with those late-night commercials making false claims."

In fiscal year 2009, the FDA conducted 184 inspections of domestic supplement establishments, according to FDA spokeswoman Pat El-Hinnawy. The agency has about 1,800 inspectors responsible for monitoring the safety and efficacy of medical devices and drugs and enforcing laws pertaining to food, supplements and cosmetics.

"While we cannot inspect every manufacturing facility, we use a risk-based system to determine the best candidates for inspection," El-Hinnawy wrote in an e-mail. The agency considers the company's history of violations, adverse event reports associated with the product, length of time since last inspection and other factors, she said.

Even when the FDA takes action, illegal and recalled products can pop up for sale online.

Last year, the agency compelled a Kentucky company to stop selling a chemical designed to treat industrial wastewater as a dietary supplement marketed to parents of children with autism. The FDA requested a recall of more than 60,000 packages of the product, called OSR#1. But until this week, a 9-gram pouch of it could be purchased on eBay for $335.

EBay removed the listing within hours of being contacted by the Tribune.

"EBay does not allow sellers to list any drugs or medication that require a prescription, nor do we allow the listing of products the FDA has identified as unapproved or otherwise in violation of their regulations," eBay spokeswoman Amanda Coffee wrote in an e-mail.

Whether any of these are caused by the products remains unknown, since supplement companies are not required to conduct clinical trials to determine what effects their products have on people.

The company stated that it tested each of its formulas on 40 or more of Timothy Ray's patients. (Ray is a retired acupuncturist.) These tests, involving balances and imbalances according to Chinese herbology, "would show safety and efficacy as it showed whether the formula is bringing the body into balance measured against these parameters," a company spokesperson wrote.

In its forums, BioRay staff responded to customer concerns by writing that reported symptoms, which the company sometimes refers to as "aggravations," are likely the result of "ramping up too quickly."

Responding to a customer asking about heart palpitations, BioRay staffer Tami Wilken wrote, "Heart palpitations can be a sign of anxiety. Experiencing this as you are ramping up the dose of any product can be the result of detoxing too quickly and is considered an aggravation."

On its website, the company referred repeatedly to the possibility of experiencing a "healing crisis," — "when the body tries to eliminate large amounts of toxins at a faster rate than the body can eliminate efficiently." Symptoms of a "healing crisis," according to a paper written by Timothy Ray and posted, until recently, on the company website, include acute nausea, vomiting, fever, fatigue, hair loss and confusion.

Asked by the Tribune what a "healing crisis" is, the company responded, in an e-mail: "I do not understand this question" and removed references to "healing crisis" on its website.

The company stated that there have been no adverse events — they are defined by the FDA as "any health-related event associated with the use of a dietary supplement that is adverse" — reported to BioRay. In an e-mail, a BioRay representative wrote that the company "has had no reportable incidents."

Supplement companies are required to report serious adverse events, such as product-linked deaths or hospitalizations, to the FDA. In 2008, companies reported more than 940 adverse events — about 600 were serious, according to a government report. The FDA estimates the actual number of mild, moderate and serious adverse events to be closer to 50,000 a year, according to the report.

The difficulty with supplements, Wolfe said, is that it's impossible to weigh risks against benefits because, in most cases, both are unknown.

Take, for example, BioRay's statement on its website that CytoFlora can "push pathogens from the gastrointestinal tract," and "correct microbial imbalances." CytoFlora, which contains dead bacteria associated with probiotics, sells for $87 for 4 ounces.

"There's no evidence that dead or parts of dead bacteria have anything to do with proliferation of good bacteria," said Dr. Allan Walker, a probiotic expert and director of the Mucosal Immunology Laboratory at Massachusetts General Hospital. There's no proof they can push pathogens out or correct microbial imbalances either, he said.

After questioning by the Tribune, BioRay removed these claims from its website.

BioRay sent the Tribune 23 references to scientific studies it said support its product claims. Most of the references were small preliminary studies performed on mice, rats or in test tubes or petri dishes. None of the studies involved placebo-controlled testing of any ingredient in BioRay products in human beings.

MacKay, of the supplement industry trade association, said there are two solutions — enforcement of laws and developing savvy consumers who can spot exaggerated or false claims.

"Consumers need helpful tips to identify false and misleading claims," MacKay said. "If it is too good to be true, it likely is."